Background/Purpose: Colchicine is the mainstay of treatment for prevention of attacks and associated amyloidosis in Familial Mediterranean Fever (FMF). Two approved colchicine preparations are currently available in Turkish market. In case of resistance or adverse effects, it is a common practice for Turkish rheumatologists to change the colchicine preparation with an imported one. The aim of this study was to assess the benefit of the imported colchicine in Turkish adult patients with FMF resistant or intolerant to domestic colchicine preparations.

Methods: Adult patients followed up with a clinical diagnosis of FMF, meeting Tel Hashomer criteria, resistant or intolerant to domestic colchicine preparations, and under treatment with a particular brand of imported colchicine were identified retrospectively and included in the study. Patients using anti-interleukin-1 or other biological agents were excluded. Disease characterisitcs, MEditerranean FeVer gene (MEFV) mutations, attack frequencies before and after the imported colchicine were specified for each patient from their medical records. Resistance to colchicine was defined as suggested by the EULAR. Frequency of attacks and colchicine doses before and after the imported colchicine were compared. Mann-Whitney U or Kruskal-Wallis tests were used for comparison of distributions of unrelated samples and Wilcoxon signed rank test for repeated measurements. p< 0.05 was considered statistically significant.

Results: A total of 59 patients were included in the study. Thirty-six (61%) patients were female and median age was 29 (interquartile range: 22-38) years. Median duration of disease was 6 (interquartile range: 2-14) years. There were 46 (78%) patients carrying exon 10 mutations in homozygous or compound heterozygous forms. Eight (14%) patients had isolated exon 10 mutations in heterozygous form and three (5.1%) had an exon 10 and the E148Q mutations together. No patient had isolated E148Q mutation in homo- or heterozygous forms. Mutant allele frequencies and characteristics of the attacks were given in Figure 1.

Fifty (84.8%) and 9 (15.2%) patients had resistance and intolerance to domestic colchicine preparations, respectively. Median number of attacks in the last three months before the imported colchicine was three (range 0-6). Although daily colchicine doses did not differ before and after the imported colchicine, number of attacks per year significantly reduced both in resistant and intolerant cases (Figure 2) after a median follow up of 19 (range 8-60) months under the imported colchicine. The decrease in number of attacks were more prominent in resistant cases (Figure 2).

Pharmacokinetic studies performed with different brands of colchicine after single oral doses in healthy subjects or FMF patients with normal renal and hepatic functions were summarized in Table 1.

Conclusion: Turkish FMF patients with ongoing attacks under domestic colchicine preparations may benefit from imported colchicine. This seems to be explainable by difference in pharmacokinetic properties of different colchicine preparations.

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ACR Meeting Abstracts - https://acrabstracts.org/abstract/different-colchicine-preparations-for-familial-mediterranean-fever-are-they-the-same/